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BROCHURE

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Antibiotic

REMECLAR 500

REMECLAR

TABLETS

Prescription only medicine

 

1. PRESENTATION:  

Each Film coated Tablet contains:

Clarithromycin ……… 250mg

Excipients: Microcrystalline Cellulose, Sodium Starch Glycollate, Colloidal Silicon Dioxide, Magnesium Stearate, Hypromellose, Macrogol 400, Titanium Dioxide, Talc, Povidone, Quinoline Yellow E104, Orange Flavour.

WHAT Remeclar IS AND WHAT ITS USES ARE

Clarithromycin, the active substance of Remeclar, belongs to the group of antibiotics called macrolides.  It is used in the treatment of bacterial infections appearing in various parts of our body.  By its action Clarithromycin kills the microbes or inhibits their development.  It should not be administered in the common cold, influenza or other infections caused by viruses.

 

2. INDICATIONS

Remeclar is indicated for the treatment of infections caused by strains of susceptible bacteria.

Respiratory tract infections: acute and chronic bronchitis, pneumonia, sinusitis and pharyngitis.

Skin and soft tissue infections of mild to moderate severity.  Remeclar is also indicated for the eradication of the helicobacter pylori in patients with duodenal ulcer.

 

3. DOSAGE AND ADMINISTRATION

Follow your doctor’s instructions.

Respiratory, skin and soft tissue infections:

Adults: 250mg twice daily for 7 days.  The dose may be increased to 500mg twice daily for up to 14 days in severe infections.

Children over 12 years old: Same as adults

H. pylori-associated infection with duodenal ulcer (Adults):

Triple therapy (7-14 days)

500mg clarithromycin twice daily with lansoprazole 30mg twice daily should be given with 1000mg amoxicillin twice daily for 7 – 14 days.

Triple therapy(7 days)

500mg clarithromycin twice daily with lansoprazole 30mg twice daily should be given with metronidazole 400mg twice daily for 7 days.

Triple therapy(7 days)

500mg twice daily and omeprazole 40mg daily should be given with 1000mg amoxicillin twice daily for 7 days

Triple therapy(10 days)

500mg clarithromycin twice daily should be given with 1000mg amoxicillin twice daily and omeprazole 20mg daily for 10 days.

Dual therapy(14 days)

500mg clarithromycin 3 times daily for 14 days. Remeclar should be administered with omeprazole 40mg once daily for 28 days.

Elderly: As for adults

Renal impairment: 250mg once daily or 250mg twice daily in more severe infections.

Remeclar can be taken either with or without food.

Duration of Treatment:

For the complete eradication of the infection, continue taking the drug for the whole period of treatment prescribed by the doctor, even if you feel better after a few days.  If you stop taking the medicine abruptly without completing the treatment the symptoms may recur.

Clarithromycin is more effective when there is a constant concentration in the blood. Therefore, you should not stop taking the doses at constant time intervals, day and night.  If, for example, you are to take 2 doses per 24 hours, then there must be an interval of 12 hours between every dose.  If this interferes with your sleep or your every day activities or if you need assistance for scheduling the time that you will take the medicine, then consult your doctor or pharmacist.

If you take a dose of Remeclar larger than normal:

In case you have taken a dose larger than normal, contact your doctor immediately.

Overdosage symptoms: gastro-intestinal symptoms and rarely altered mental status, paranoid behaviour, hypokalemia and hypoxemia.

Adverse reactions accompanying overdosage should be treated by gastric lavage and supportive measures.

What you should know if you forget to take a dose:

If you have to take the medicine continuously and you miss taking a dose, take the missed dose as soon as possible.  However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take double doses. In case you missed more than one dose consult your doctor because it may be necessary for the treatment to start again.

 

4. CONTRAIDICATIONS

Clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs.  Clarithromycin and ergot derivatives should not be co-administered.

Concomitant administration of clarithromycin and any of the following drugs is contra-indicated: cisapride, pimozide and terfenadine.  Elevated cisapride, pimozide and terfenadine levels have been reported in patients receiving either of these drugs and clarithromycin concomitantly.  This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade de Pointes.  Similar effects have been observed with concomitant administration of astemizole and other macrolides.

 

5. WARNINGS & PRECAUTIONS:

Clarithromycin is principally excreted by the liver and kidney. Caution should be exercised in administering this antibiotic to patients with impaired hepatic or renal function.

Prolonged or repeated used of clarithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If super-infection occurs, clarithromycin should be discontinued and appropriate therapy instituted.

H. pylori organisms may develop resistance to clarithromycin in a small number of patients.

There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see section 4.5).

 

6. PREGNACY AND LACTATION:

Pregnancy:

Clarithromycin should not be used during pregnancy.

Consult your doctor or pharmacist before taking any medicine.

Lactation:

It should be used cautiously during lactation as it is not known if it is excreted into human milk.

Consult your doctor or pharmacist before taking any medicine.

 

7. DRIVING AND OPERATING MACHINERY:

Caution is required as Clarithromycin may cause dizziness.

 

8. UNDESIRABLE EFFECTS

As with all medicines Remeclar may cause undesirable effects.

Most usual are:

Nausea, vomiting, dyspepsia, intestinal upsets, diarrhoea, urticaria, rashes and other allergic reactions, loss of hearing following large doses which is reversible on withdrawal of the drug, cholestatic jaundice, hepatitis, headache, disorders in the sense of smell and taste, discolouration of teeth and tongue, stomatitis, glossitis, arthralgia, myalgia, dizziness, vertigo, tinnitus, agitation, insomnia, nightmares, confusion, psychosis, hypoglycaemia, Stevens-Johnson syndrome, tachycardia.

If you experience undesirable effects not mentioned above, please contact your doctor.

 

9. DRUG INTERACTIONS:

A number of medicines interact with Clarithromycin and should not be used concomitantly with clarithromycin. However, a few of them can be used concomitantly under special precautions. In this case, your doctor can change the posology or take other precautions if needed.  If you are about to take Clarithromycin it is important to inform your doctor or pharmacist if you are taking any other medications and in particular any of the following: 

Theophylline, carbamazepine, midazolam, triazolam, alprazolam, sildenafil, quinidine, tacrolimus, warfarin, digoxin, ergotamine or dihydroergotamine, phenytoin, disopyramide, symvastatin or lovastatin, cyclosporine, zidovudine, rifabutin, ritonavir, ranitidine, colchicine, omeprazole, Maalox.

 

10. PHARMACODYNAMIC PROPERTIES

Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by binding to the 50s ribosomal sub-unit of susceptible bacteria and suppresses protein synthesis. It is highly potent against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms. The minimum inhibitory concentrations (MICs) of clarithromycin are generally two-fold lower than the MICs of erythromycin.

The 14-hydroxy metabolite of clarithromycin also has antimicrobial activity. The MICs of this metabolite are equal or two-fold higher than the MICs of the parent compound, except for H. influenzae where the 14-hydroxy metabolite is two-fold more active than the parent compound

Remeclar is usually active against the following organisms in vitro:

Gram-positive Bacteria: Staphylococcus aureus (methicillin susceptible); Streptococcus pyogenes (Group A beta-hemolytic streptococci), alpha-hemolytic streptococci (viridans group); Streptococcus (Diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.

Gram-negative Bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae; Legionella pneumophila, Bordetella pertussis, Helicobacter pylori; Campylobacter jejuni.

Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.

Other Organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae.

Anaerobes: Macrolide-susceptible Bacteroides fragilis; Clostridium perfringens; Peptococcus species; Peptostreptococcus species; Propionibacterium acnes.

Clarithromycin has bactericidal activity against several bacterial strains. The organisms include Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus

agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, H. pylori and Campylobacter spp. The activity of clarithromycin against H. pylori is greater at neutral pH than at acid pH.

 

11. PHARMACOKINETIC PROPERTIES

Clarithromycin is rapidly and well absorbed from the gastro-intestinal tract after oral administration. The microbiologically active metabolite 14-hydroxyclarithromycin is formed by first pass metabolism. Remeclar may be given without regard to meals as food does not affect the extent of bioavailability of Remeclar tablets. Food does slightly delay the onset of absorption of clarithromycin and formation of the 14-hydroxymetabolite. The pharmacokinetics of clarithromycin are non linear; however, steady-state is attained within 2 days of dosing. At 250 mg b.i.d. 15-20% of unchanged drug is excreted in the urine. With 250 mg b.i.d. daily dosing urinary excretion is greater (approximately 36%). The 14-hydroxyclarithromycin is the major urinary metabolite and accounts for 10-15% of the dose. Most of the remainder of the dose is eliminated in the faeces, primarily via the bile. 5-10% of the parent drug is recovered from the faeces.

When clarithromycin 250 mg is given three times daily, the clarithromycin plasma concentrations are increased with respect to the 250 mg twice daily dosage.

Remeclar provides tissue concentrations that are several times higher than the circulating drug levels. Increased levels have been found in both tonsillar and lung tissue. Clarithromycin is 80% bound to plasma proteins at therapeutic levels.

Remeclar also penetrates the gastric mucus. Levels of clarithromycin in gastric mucus and gastric tissue are higher when clarithromycin is co-administered with omeprazole than when clarithromycin is administered alone.

 

12. SHELF LIFE:  36 months      

 

13. STORAGE:  It is stored below 25OC, away from light and moisture and in a safe place out of the reach of children.

 

14. SPECIFICATION: Manufactured ‘specification                   

 

Name and Address of Manufacturer

Remedica Ltd,

Limassol Industrial Estate, Limassol, Cyprus, EU   

 

Name and Address of Registrationer:

Nhat Anh Pharmaceutical Co., Ltd

122/7-9 Dang Van Ngu Str., ward 14, Phu Nhuan district, HCM city

                       

                                                                       

Please read carefully before use.

Further more information please ask your doctor or pharmacist

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